Phase 3 N=221 Diagnostic

18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02680041 ↗

Enrolled (actual)

221

Serious AEs

0.0%

Results posted

Jan 2019

Primary outcome: Primary: The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. — 126; 87; 88; 34 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 18F-fluciclovine PET CT (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Blue Earth Diagnostics
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.	126; 87; 88; 34; 38; 53	—
SECONDARY The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment	80; 131; 47; 74; 33; 57	—
SECONDARY The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population	122	—
SECONDARY The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population	64; 80	—
SECONDARY The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy	100	—
SECONDARY The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy	100	—

Summary

This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.

Eligibility Criteria

Inclusion Criteria

History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second confirmatory level of >0.2 ng/mL
Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis).
Being considered for salvage therapy
Any non-surgical local treatment such as previous cryotherapy, external beam radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.
Previous brachytherapy treatment will have occurred at least 2 years in the past
Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)
Androgen deprivation therapy (ADT) in the past 3 months
History of bilateral orchidectomy
Inability to tolerate 18F-fluciclovine PET/CT

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02680041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.